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IXP

Phase 1

Renal Impairment | Small molecule | Nephrology |Vertex Pharmaceuticals Incorporated|Last Updated: Jul 12, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05865171A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal ImpairmentPHASE1 COMPLETED 16 — — Jun 12, 2023Jun 12, 2024Jul 12, 20242 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of IXP
Day 1 up to Day 7
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
Day 1 up to Day 7
Secondary Endpoints
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Day 1 through completion of study participation (up to a maximum of 17 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1: Severe Renal ImpairmentEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Cohort 1: Healthy ParticipantsEXPERIMENTALParticipants will receive a single dose of IXP on Day 1.
Interventions
NameTypeDescription
IXPDRUGTablets for oral administration.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: * Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m\^2) * Stable renal function for at least 1 month prior to enrollment Key Exclusion Criteria: * Uncontrolled hypertension * Any condition possibly affecting drug absorption Other protocol defined Inclu...

Countries:United States
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